Quality Systems Leader - MedTech Lab

BD; Covington (VA); On-site; USD 65,000 - 95,000; Full time

Job summary

BD is seeking a Quality Specialist to support laboratory operations with quality expertise across medical product testing, ensuring compliance with ISO 13485, ISO 17025, and 21 CFR Part 820. The role emphasizes continuous improvement and operational excellence in a regulated environment.

You will lead Quality System processes, document control, CAPAs, and audits, while mentoring staff and driving cross-functional quality initiatives.

Qualifications

• Bachelor's degree in laboratory related science (Chemistry, Microbiology or related field).
• 2 years of experience in a laboratory associated with a regulated industry.
• Knowledge and experience with Medical Device regulations, ISO 13485 and 21 CFR 820 as well as ISO 17025.
• 2 years of experience in a laboratory in Med device or pharma industry.
• ASQ Certified Quality Engineer, Quality Auditor.

Responsibilities

• Coordinate and maintain a robust, standardized laboratory Quality System aligned with regulatory requirements.
• Serve as local SME for Quality Systems, ensuring compliance and guidance across the organization.
• Ensure laboratory processes meet business needs and regulatory expectations.
• Promote quality culture and awareness of ISO, QSR, and related regulations.
• Lead implementation of Quality System processes to achieve performance and compliance goals.
• Support and maintain document control and record management.
• Lead local Quality Objectives and Key Business Drivers for laboratory operations.
• Participate in Quality Leadership meetings and ensure progress of quality initiatives.
• Use metrics to monitor effectiveness, identify improvements, and deliver value.
• Drive continuous improvement through lessons learned and proactive problem prevention.
• Support development of local quality organization via training and mentorship.
• Oversee training programs, GMP/GDP compliance, LIMS operations, QMS audits, data reporting, nonconformances, ISO 17025 activities, supplier quality, and investigations.
• Assist with CAPAs, validations, calibrations, OOS investigations, and general quality activities.
• Plan and participate in internal and external audits; ensure regulatory compliance.

Skills

Excel

Word

PowerPoint

Process oriented

Continuous Improvement

Organization

Analytical skills

Interpersonal skills

Project leadership

Initiative

Education

Bachelor's degree in laboratory related science

2 years of experience in a regulated-lab

Job description

BD is seeking a Quality Specialist to support laboratory operations with quality expertise across medical product testing, ensuring compliance with ISO 13485, ISO 17025, and 21 CFR Part 820. The role emphasizes continuous improvement and operational excellence in a regulated environment.

You will lead Quality System processes, document control, CAPAs, and audits, while mentoring staff and driving cross-functional quality initiatives.